Maybe you are correct Karl (??) . However , that would appear to imply that you knowledge base is stronger than Uncle Keith ( Oct 7th , 2014 ) : UNILIFE’S CONTRIBUTION TO ALIROCUMAB Sanofi has tested alirocumab for patients with hypercholesterolemia that meet certain criteria – specifically, the individuals may be statin intolerant and considered at high risk, have heterozygous familial hypercholesterolemia, recently had a heart attack, or are diabetic and have two risk factors which may or may not include a recent heart attack. This population, which numbers 21 million in the United States and Europe, comprises the company’s initial, targeted market.24 Eventually, research may support the use of alirocumab to include most statin-insensitive patients and diabetics with one or even no additional risk factors. That expansion would increase the patient population by about 70%, to 36 million. We believe alirocumab is the keystone to the long-term wearable injector deal between Unilife and Sanofi. That’s partly because of the importance of the drug to the pharmaceutical collaborators (Sanofi and Regeneron) and partly because of the contribution that the devices will likely make to the drug’s commercialization. Indeed, three different 20 Clarke, R, et al. Genet ic variants associated with Lp(a) lipoprotein level and coronary disease. N Engl J Med (2009); 361(26) : 2518. 21 Gaudet , D, et al. Effect of alirocumab, a monoclonal proprotein convertase subt ilisin/kexin 9 ant ibody, on lipoprotein( a) concent rat ions (a pooled analysis of 150 mg every two weeks dosing from Phase 2 t rials). Am J Cardiol, epub June 18, 2014. 22 Cannon, CP, et al. Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med (2004); 350(15): 1495. 23 Norata, GD, et al. PCSK9 inhibit ion for the t reatment of hypercholesterolemia: Promises and emerging challenges. Vascul Pharmacol (2014); 62(2): 103. 24 Sanofi/Regeneron Presentat ion: IR Themat ic Call on Alirocumab, conducted on September 2 , 2014. Unilife creations may be used to administer alirocumab, a prefilled syringe, a disposable autoinjector and the wearable injectors. We base this on Sanofi’s use of these types of devices in its alirocumab clinical trials – prefilled syringes and autoinjectors were used for dosing once every two weeks and the wearable injectors were used by patients receiving the drug once monthly. But then, the devices also meet three other ingredients to success: Unilife’s designs are convenient for both the drug manufacturers and patients. The elimination of terminal sterilization (i.e., sterilization after the drug has been loaded into the device) reduces the threat of this process to a biological agent’s integrity, since heat causes biological molecules to denature and the alternative, radiation, adds to the cost. For the patient, the devices are prefilled, ready for use. Unilife designs eliminate complexity that is seen with other devices that require assembly and adjustment of the dose to be delivered. This, plus the visual, tactile, and audible signals built into the models, reduces the risk of inaccurate or incomplete dosing by the patient or care provider. Finally, the Unilife designs are cost efficient – the devices cost relatively little compared to the price of today’s biological agents. Moreover, the wearable injectors can be Bluetooth enabled, meaning that they can remind a patient to take the drug via a message sent to a smart phone and/or confirm to the treating physician or patient’s healthcare insurer of compliance with the prescribed therapy.
